Fluval P |
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The "Fluval P" is a vaccine against swine flu (H1N1 virus). The vaccine uses the split virus made by CSL Biotherapies in Australia.
Who will be recommended to receive the 2009 H1N1 vaccine? CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended that certain groups of the population receive the 2009 H1N1 vaccine when it first becomes available. These target groups include pregnant women, people who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, persons between the ages of 6 months and 24 years old, and people ages of 25 through 64 years of age who are at higher risk for 2009 H1N1 because of chronic health disorders or compromised immune systems.
h1n1 virus, flu bird, swine virus, shot flu, shots flu, flu kids, who h1n1, flu reaction, epidemic flu.
| Dosage |
Packing |
Price |
Add to basket |
| 1 amp |
0.5 ml vial ($29 per vial) |
USD 29.00 |
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| 5 vilas |
0.5 ml vial ($27 per vial) |
USD 135.00 |
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| 20 vials |
0.5 ml vial ($25 per vial) |
USD 499.00 |
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| 40 vials |
0.5 ml vial ($23 per vial) |
USD 920.00 |
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Fluval P: Medications and Prescriptions
Product Brand Name: Fluval P
Product Manufacturer: manufactured in EU
Fluval P description
Influenza A (H1N1) and the 2009 Influenza Pandemic:
Swine influenza (swine flu) is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs. Swine flu viruses cause high levels of illness and low death rates in pigs. Swine influenza viruses may circulate among swine throughout the year, although most outbreaks occur during the late fall and winter months, similar to outbreaks in humans. The classical swine flu virus (an influenza type A H1N1 virus) was first isolated from a pig in 1930 (Influenza: Pigs, people and public health. Public heath fact sheet (January 2004)).
Like all influenza viruses, swine flu viruses change constantly. Pigs can be infected by avian influenza and human influenza viruses as well as swine influenza viruses. When influenza viruses from different species infect pigs, the viruses can reassort (i.e. swap genes) and new viruses that are a mix of swine, human and/or avian influenza viruses can emerge. Over the years, different variations of swine flu viruses have emerged. At this time, four influenza type A virus subtypes are enzootic in pigs worldwide: H1N1, H1N2, H3N2, and H3N1 (Osterhaus, A. and Garau, J., 2009). However, most of the recently isolated influenza viruses from pigs have been H1N1 viruses.
Although it is not a common occurrence, swine flu may be transmitted from pigs to humans who are in close direct contact with the animals, or vice versa (see Genetic relationships among human and swine influenza viruses, 1918-2009 (National Institute of Allergy and Infectious Diseases)). The incidence of swine flu in humans is normally quite low: according to the Centers for Disease Control and Prevention (CDC), between 2005 and January 2009, there were only 11 confirmed cases of the illness in the entire U.S., most in persons who had been in contact with swine, although it is likely that many more unreported cases also occurred during that time period (Shinde, V. et al., 2009; Zimmer, S.M. and Burke, D.S., 2009). In spring 2009, however, an outbreak occurred in Mexico and
spread quickly to parts of the U.S., with other travel-related cases reported soon thereafter in various European and Asian countries (Khan, K. et al., 2009). A new strain of the H1N1 virus is
responsible for these cases. The virus contains genetic elements from four different sources: North American swine influenza viruses, North American avian influenza viruses, human influenza viruses
and a Eurasian swine influenza virus (Neumann, G. et al., 2009). The genome sequences of the virus, officially designated swine-origin influenza A/California/04/2009 (H1N1) influenza virus (since
shortened to H1N1/09 virus), available through GenBank (GenBank sequences from 2009 H1N1 influenza outbreak). The new virus manifests significant changes in both the hemagglutinin and
neuraminidase proteins as compared to H1N1 isolates from 2008: 27.2% and 18.2% of the amino acid sequences of H and N, respectively, vary from comparator strains. A change of this magnitude may qualify as "antigenic shift", endowing the virus with pandemic potential (Gallaher, W.R., 2009). Furthermore, CDC investigators suggest that the gene segments of the novel influenza virus may have been circulating undetected for an extended period of time. Its introduction from swine into humans was either a single event or multiple events with similar viruses (Garten, R.J. et al., 2009),
and appears to have taken place several months before the outbreak was recognized (Smith, G.J. et al., 2009). Of interest is the finding that the H1N1 virus currently lacks the protein PB1-F2, which is believed to be an important determinant of virulence and lethality in influenza viruses (Osterhaus, A. and Garau, J., 2009). The virus has also been found to have glutamic acid rather than lysine at position 627 on the PB2 protein; this mutation endows the virus with relatively lower pathogenicity and reduced persistence in the throat and nose, but makes it more likely to migrate to and replicate in the lung (Neumann, G. et al., 2009).
On April 27, WHO raised the pandemic alert level to phase 4, meaning that the virus had shown a sustained ability for human-to-human transmission and the ability to cause community-level outbreaks. On April 29, WHO raised the pandemic alert level to phase 5. This acknowledges efficient community-level human-to-human transmission of the virus in at least two countries within a single WHO region. WHO has issued guidelines for surveillance of the swine flu virus (Human infection with pandemic (H1N1) 2009 virus: Updated interim WHO guidance on global surveillance (World Health Organization, July 10, 2009)).
On June 11, the WHO raised the level of influenza pandemic alert from phase 5 to phase 6, reflecting the fact that, in addition to the criteria defined in phase 5, the virus has caused sustained
community-level outbreaks in at least one other country in another WHO region. In a press conference held to announce the start of the 2009 influenza pandemic, WHO Director General Margaret Chan stressed that globally, the virus appeared to be of only moderate severity, with a relatively small number of deaths. However, most of the reported cases at that time had been in high-resource countries. As the new influenza virus reaches underdeveloped countries with limited
healthcare resources, disproportionately high levels of maternal deaths and chronic disease, she said, it is "prudent to anticipate a bleaker picture." The 2009 influenza pandemic has spread internationally with unprecedented speed. In past pandemics, influenza viruses have needed more than six months to spread as widely as the new H1N1 virus spread in less than six weeks. In the face of this fact, WHO has indicated that countries with widespread transmission should now focus their healthcare resources on patient management and monitoring of big trends in the spread of disease, rather than the surveillance and testing of individual suspected cases (Zarocostas, J., 2009).
On July 16, acknowledging that further spread of the virus was inevitable, WHO announced new reporting requirements for the pandemic virus (Pandemic (H1N1) 2009 briefing note 3 - Changes in reporting requirements for pandemic (H1N1) 2009 virus infection (WHO, July 16, 2009)). Furthermore, historical data shows that pandemic influenza viruses gain in severity and transmissibility over time, leading health officials to fear that the Northern hemisphere's 2009-2010 flu season could be much more serious. However, these trends are difficult to track in the face of low reporting of mild cases and reduced surveillance in hard-hit
countries (Lipsitch, M. et al., 2009). By late August 2009, however, the pandemic H1N1 virus was acknowledged by WHO to be the predominant strain of influenza circulating in both the northern and
southern hemispheres. Viral transmission patterns in the southern hemisphere have been closely watched by WHO and CDC (Fraser, C. et al., 2009) and on the basis of this vigilance, WHO issued new recommendations in late August (Preparing for the second wave: lessons from current outbreaks (World Health Organization, 28 August, 2009). Also in late August, the U.S. government released a
preliminary report on pandemic influenza activity during the southern hemisphere's influenza season. The report concluded that the pandemic virus had remained antigenically stable in the five
countries selected for surveillance, with continued susceptibility to antiviral neuraminidase inhibitors and no signs of increased virulence (Assessment of the 2009 influenza A (H1N1) pandemic on selected countries in the southern hemisphere: Argentina, Australia, Chile, New Zealand and Uruguay (U.S. Department of Health and Human Services, August 26, 2009)).
The World Health Organization has reported that, as of October 4, 2009, more than 378,223 laboratory-confirmed cases of influenza A (H1N1) infection have been officially registered worldwide, including more than 4,525 deaths. The WHO continues to stress that countries are no longer required to test and report individual cases, and as such the number of cases reported actually understates the real number of cases. WHO regional reports for the Americas indicates a cumulative total of 146,016 confirmed cases and 3,292 deaths in the region as of October 2. The U.S. CDC, which has stopped reporting cumulative numbers of cases, registered 16,174 new
influenza- and pneumonia-associated hospitalizations and 1,379 cumulative deaths (including 2009 H1N1 and seasonal flu) between August 30-September 26, 2009. In the U.S., widespread influenza
activity was reported in 27 states, and 99% of all subtyped influenza A viruses reported to CDC were H1N1.
As of 5 October 2009, the European Centre for Disease Prevention and Control had reported 189 H1N1-related deaths, but has also stopped tabulating individual cases. In the southern hemisphere, most countries appear to have passed the peak of influenza activity and are now returning toward baseline levels. Australia has reported 36,670 confirmed cases and 183 deaths, with the country's indigenous population suffering a disproportionately high mortality rate (data from Australian Government Department of Health and Ageing, 2 October 2009). Brazil has highest H1N1-related fatality rate, with 9,249 confirmed cases and 899 deaths (data from WHO's regional
office for the Americas, 2 October 2009). South Africa has reported 11,729 laboratory-confirmed cases and 84 fatalities (data from South Africa's National Institute for Communicable Diseases, 1 October 2009), while Thailand has registered 23,867 cases and 160 deaths, and India has confirmed 7,925 cases and 240 fatalities as of 20 September, 2009 (information from WHO's regional office for Southeast Asia). Additional infections, as well as smaller numbers of fatalities, have been confirmed in most countries around the world (see Pandemic (H1N1) 2009 laboratoryconfirmed cases and numbers of deaths as reported to WHO - Status as of 4 October 2009 for latest world map from WHO). In all countries the real numbers of H1N1/09 flu cases are acknowledged to be far higher than the officially reported numbers reflect. By August 2009, CDC estimated that at least one million people had been infected with the novel influenza virus in the U.S. alone (Anonymous, 2009).
CDC has developed a polymerase chain reaction (PCR) diagnostic test kit, the rRT-PCR Swine Flu Panel diagnostic test, to detect the novel H1N1 virus. Test kits have been distributed to 250 public
health and other qualified laboratories around the world. This will allow states and other countries to test for this new virus. CDC says that the increase in testing capacity is likely to result in an increase in the number of reported confirmed cases, which should provide a more accurate picture of the burden of disease. Researchers from the National Institute of Allergy and Infectious Diseases (NIAID) have since described an improved method with increased sensitivity for distinguishing H1N1 of human origin from swine-origin H1N1 using real-time RT-PCR (Wang, R. et al., 2009). CDC
has issued interim guidance providing an overview of the sensitivities of various rapid influenza diagnostic tests (RIDT) in detecting novel influenza A (H1N1) virus in order to help guide the
reporting and interpretation of test results (Interim guidance for the detection of novel influenza A virus using rapid influenza diagnostic tests (Centers for Disease Control and Prevention, August 10, 2009)).
The virus is transmitted by droplets (i.e., contaminated droplets in the air or on objects prooceeding from an infected individual who coughs or sneezes. Aerosol transmission may also occur. The virus
appears to be contagious beginning one day before symptoms emerge and lasting for at least seven days after symptoms appear. It is most contagious during the first five days, and in children
may remain contagious for up to ten days (Osterhaus, A. and Garau, J., 2009). Predominant symptoms of the new influenza A (H1N1/09) virus include sudden-onset high fever, dry cough, muscular pain, headache, chills and fatigue. Some infected people (as many as 25%) may also have nausea, vomiting and diarrhea. Runny nose and sore throat are less common than with seasonal influenza. The virus preferentially infects young people (i.e., under 25 years of age),
although most of these cases have been mild. Rapidly progressing lower respiratory tract disease leading to respiratory failure and/or acute respiratory distress syndrome (see Acute Respiratory
Distress Syndrome and Acute Lung Injury), often requiring admission to the intensive care unit, has been detected most frequently in children under 4 years, adults over 65 years, those with underlying
chronic medical conditions --especially respiratory diseases such as asthma or chronic lung disease, cardiovascular disease and autoimmune disorders-- and pregnant women (Osterhaus, A. and Garau, J., 2009; Anonymous, 2009; Jamieson, D.J. et al., 2009). The fact that the virus is so lethal in pregnant women is significant, given that young adults are so susceptible to this strain of influenza (see Considerations regarding novel H1N1 flu virus in obstetric settings (Centers for Disease Control and Prevention, July 6, 2009) for new guidance). Metabolic syndrome, including obesity which
has not been identified as a risk factor in previous pandemics or with seasonal influenza, is reported as another significant risk factor for severe disease (Vaillant, L. et al., 2009). However, the disease is also capable of causing severe and even fatal respiratory disease in young, otherwise healthy individuals without preexisting medicl conditions (Perez-Padilla, R. et al., 2009; Chowell, G. et al., 2009). A study by the CDC of fatal cases in the U.S. has determined that bacterial coinfection, in many cases caused by Steptococcus pneumoniae, is a frequent case of fatal disease (Bacterial coinfections in lung tissue specimens from fatal cases of 2009 pandemic influenza A (H1N1) -- United States, May-August 2009 (Centers for Disease Control and Prevention, September 29, 2009)).
Epidemiology experts from WHO and collaborators have estimated that the case fatality rate of the H1N1 virus may be as high as 0.4% (Fraser, C. et al., 2009), a figure four times higher than that of
seasonal influenza. World Health Organization officials predict up to 2 billion people will eventually be infected -- which could raise the overall number of deaths over an average flu season even if the
virus itself is not especially pathogenic.
Treatment:
The influenza A (H1N1) virus is susceptible to treatment with the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza), but not to amantadine or rimantadine (Anonymous,
2009; Anonymous, 2009). Pregnant women are at increased risk for severe or fatal complications; for this reason CDC has mandated that pregnant women with confirmed, probable, or suspected novel
influenza A (H1N1) virus infection should receive immediate antiviral treatment, preferably with oseltamivir, for 5 days (Anonymous, 2009; Jamieson, D.J. et al., 2009). Investigators from the University of Hong Kong, together with collaborators from the U.K. and U.S., have recommended that small stockpiles of a secondary flu medication, in this case zanamivir, used judiciously in
approximately 1% of the population, could extend the effectiveness of stockpiles of the primary antiviral medication, oseltamivir, by delaying the development of resistance (Wu, J.T. et al., 2009).
The U.S. FDA has released Emergency Use Authorizations enabling wider use of oseltamivir and zanamivir in treating patients with swine flu, and WHO and CDC have issued treatment guidelines
(see Infection prevention and control in health care in providing care for confirmed or suspected A(H1N1) swine influenza patients: Interim guidance (World Health Organization, April 29, 2009) and Updated interim recommendations for the use of antiviral medications in the treatment and prevention of influenza for the 2009-2010 season (Department of Health & Human Services, September 2009)).
On July 1, Roche announced the initiation of the Tamiflu Reserves Program (TRP) for developing economies. The program, which became effective immediately, will serve to ensure that oseltamivir (Tamiflu) is available to many governments and patients in developing nations at a significantly reduced price for use when WHO has declared an influenza pandemic, or for the management of a novel
influenza strain defined by WHO that has significant and current pandemic potential. On July 8th, WHO announced that isolated cases of oseltamivir-resistant H1N1/09, as confirmed by laboratory
testing, had been reported in Denmark, Japan and Hong Kong. These viruses were found in three patients who did not have severe disease, all of whom subsequently recovered. The viruses, while
resistant to oseltamivir, remained sensitive to zanamivir. In mid-August, CDC reported two cases of oseltamivir-resistant H1N1 in the state of Washington; both patients were immunosuppressed due
to previous leukemia therapy (Oseltamivir-resistant novel influenza A (H1N1) virus infection in two immunosuppressed patients -- Seattle, Washington, 2009 (MMWR Dispatch, August 14, 2009)).
The need for a human swine flu vaccine became clear just months after the first cases were registered. WHO Director-General Dr. Margaret Chan and United Nations Secretary-General Ban
Ki-moon met on May 19, 2009 with more than 30 vaccine manufacturers from developing and developed countries. Industry representatives affirmed their cooperation in making vaccine supplies available to developing countries. WHO and CDC have provided samples of the seed virus (A/California/7/2009(H1N1)pdm) to pharma companies so that they can develop H1N1 vaccines. Companies working on H1N1/09 vaccine development include Novartis, sanofi pasteur MedImmune, Protein Sciences, CSL, GlaxoSmithKline, Vical and Baxter, among others. On
September 15, the FDA approved injectable H1N1 vaccines made by CSL, Novartis and sanofi pasteur as well as an intranasal vaccine made by MedImmune. Regulatory authorities have also licensed pandemic vaccines in Australia and China, soon to be followed by Japan and the European Union. Many governments are planning mass vaccination campaigns beginning in late September or early October. Questions regarding the number of doses that will be required for efficacy and the appropriate target population to receive limited supplies of the vaccine are beginning to be resolved (Lipsitch, M. et al., 2009). Early study results obtained with CSL's vaccine in Australia indicate that the vaccine is safe and effective as a single 15-mcg i.m. dose (Greenberg, M.E. et al., 2009), although some concerns remain regarding potential side effects such as Guillian-Barré syndrome, which emerged following a 1976 swine flu vaccination campaign (Zimmer, S.M. and Burke, D.S., 2009).
WHO's global pandemic influenza vaccine action plan was drawn up in 2006 (Kieny, M.P. et al., 2006). In September 2009, WHO recommended the composition of the influenza virus vaccine for use in the 2010 southern hemisphere influenza season; this vaccine will contain, as one of its three components, an A/California/7/2009 (H1N1)-like virus (see Recommended composition of influenza virus vaccines for use in the 2010 southern hemisphere influenza season (World Health
Organization, September 2009)). On July 7, 2009, WHO's Strategic Advisory Group of Experts (SAGE) on Immunization held an
extraordinary meeting to discuss issues and make recommendations related to a vaccine for the pandemic H1N1/09 virus. SAGE concluded that the spread of the pandemic virus is unstoppable, and hence that a vaccine will be needed in all countries. Priority should be given to first immunizing health care workers, so as to protect essential health infrastructure; countries should then establish national step-wise vaccination approach, based on country-specific conditions. WHO recommends the following groups for consideration when allocating vaccines at the national level: pregnant women; those aged above 6 months with one of several chronic medical conditions; healthy young
adults of 15 to 49 years of age; healthy children; healthy adults of 50 to 64 years of age; and healthy adults of 65 years of age and above. Additionally, since new technologies are involved in the
production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of
the highest possible quality. SAGE also emphasized the importance of striving to achieve equity among countries to access the vaccines developed.
For up-to-date information, check the specialized web sites from CDC (Centers for Disease Control and Prevention: H1N1 flu (swine flu) web site) and WHO (World Health Organization (Epidemic and
Pandemic Alert and Response) influenza A (H1N1) web site), as well as International SOS Pandemic Preparedness: Influenza H1N1 ("swine flu") homepage and New England Journal of Medicine: H1N1
Influenza Center.
Fluval P notes:
Fluval P is prescribed as a powerful vaccine against swine flu or swine virus (H1N1 virus). Swine flu is a respiratory disease of pigs that cause serious illness and low death rates in pigs. Like other influenza viruses like flu bird, epidemic flu and other flu reaction, swine flu viruses also changes frequently. Different variations of swine flu viruses have surfaced over that includes H1N1, H1N2, H3N2, H3N1 etc- the H1N1 viruses being the recently isolated influenza viruses from pigs.
The shot flu of this virus is transmitted by droplets, especially from the contaminated droplets in the air or on objects that is transmitted from an infected individual when he or she coughs or sneezes. Aerosol transmission can also come about. The shots flu of these virus are highly contagious during the first or the initial day before emerge the emergence of the symptoms and can last for at least seven days after the appearance of the symptoms. It is known to be highly contagious during the first five days. Flu kids or children infected by these viruses stay contagious for up to ten days.
There are so many associated symptoms of the new h1n1 influenza that includes the sudden-onset of high fever, muscular pain, dry cough headache, chills, fatigue etc. about 25% of infected people has been reported to suffer from vomiting, nausea, and diarrhea. Runny nose and sore throat are also some of the predominant symptoms. The virus is known to infect young people preferentially under 25 years of age. As a result of the infection, lower respiratory tract disease progresses rapidly causing respiratory failure or acute respiratory distress syndrome.
H1N1flu can be treated with the neuraminidase inhibitors like zanamivir (Relenza) and oseltamivir (Tamiflu) and Fluval P are highly essential to prevent the disease.
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Drug category:antiviral
 Fluval P
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